Policy
Department:
Policy Number:
Section:
Review Responsibility:
Original Creation Date:
Revision Dates:
HUMAN RESEARCH PROTECTIONS PROGRAM
V.B
Records, Documentation, and Fees
HRPP Policy and Procedure Committee
January 1, 2001
March 19, 2004; December 20, 2006; July 1, 2015
Subject: IRB Fees for Industry-Supported Applications
Definitions:
Industry-Supported: When a commercial entity contributes to the design or conduct of the study (as
evidenced by a sponsor’s protocol, sponsor’s identification number and/or Investigator’s brochure);
coordinates the study as a multi-center trial; reimburses VU, VUMC or a VU or VUMC Investigator for
costs associated with conducting the trial; or will have access to, or publish or present the data gained
from conducting the trial.
Policy:
It is the policy of the Human Research Protections Program to assess a fee for all industry–supported
initial IRB applications, continuing review applications, and amendments submitted to the IRB requiring
full, convened IRB Committee review or expedited IRB review.
I.
The HRPP will assess a charge for all industry-supported research submissions requiring
full, convened IRB Committee review or expedited IRB review, with the exception of
serious and unexpected adverse events and unanticipated problems involving risks to
participants or others, protocol deviations, data and safety monitoring reports that do not
require major amendments, administrative changes, and responses to IRB reviews.
A.
All initial study submissions to the IRB must identify the funding sources supporting the
proposed research.
B.
When an IRB submission is received and is not designated as industrysupported, but is later determined by the IRB to be industry-supported,
appropriate IRB fees will be assessed.
C.
Billing information must be received within 120 days of submission to the IRB or
the IRB has the authority to refuse to process additional applications from the
Investigator.
II.
IRB applications that are solely dependent on state, federal, non-profit foundations, or
internal funds will be excluded from IRB fees.
III.
Under extenuating circumstances, the HRPP Director may waive the assessment of IRB
fees with a formal request from the Investigator and appropriate documentation to
support such circumstances.
IV.
It is expected that Investigators incorporate and negotiate applicable IRB fees into the
research contract. Fees are expected in a timely manner.